【无锡 MSAT 负责人招聘】-猎头顾问无锡招聘信息-猎聘

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猎头顾问 · 优尼特联合咨询（天津）有限公司

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职位介绍: 工作职责 Key responsibilities 1负责药明合联原液生物制药科技团队的日常工作管理，领导 mAb和DS技术转移、工艺验证、审计等按进度高质量完成，确保GMP readiness，带领团队确保GMP和PPQ生产活动成功执行； Responsible for the routine operation and management of XDS Manufacturing Science and Technology team (MSAT) in Singapore TUAS site. Lead mAb and DS technology transfer, process validation, auditing, and other tasks are completed on schedule with high quality, ensure GMP readiness and the successful execution of tech transfer and PPQ runs; 2建立和持续优化抗体和原液技术转移平台和工艺验证平台，培养和提升MSAT团队能力，保证GMP 和生产技术支持的质量； Establish and continuously optimize the mAb and DS Tech Transfer platform and Process Validation platform, cultivate and enhance MSAT team capabilities, and ensure the quality of GMP and production technology support; 3负责MSAT实验室管理，确保GMP生产相关的 use test，scale up，tech transfer run, trouble-shooting等成功完成； Be responsible for MSAT lab management, carry out use test, scale up, tech transfer run, trouble-shooting etc. to support GMP manufacturing; 4领导团队完成官方审计和客户审计的准备、现场应对和发现项的整改回复； Lead team in preparation for official and customer audits, on-site responses and corrective responses to findings; 5负责与内外部团队沟通，解决跨部门问题； Be responsible for communicate with internal and external teams, solving cross-function issues; 6负责协助新项目的评估与引进，参与和主导项目技术转移、工艺适配性分析和投产； Be responsible for participate and assist project team to perform new project introduction and assessment for new client. Participate and lead project tech-transfer, process fit and GMP implementation; 7负责部门的日常事务管理，包括且不限于日常运营、招聘、晋升等，使团队有序运行； Be responsible for the daily management of the department, include but not limited to daily operation, recruitment, promotion, etc., to make the team run orderly； 8搭建员工培训体系和SME技术人才培养体系，负责团队所有相关人员都已经过必要的上岗前培训和继续培训、团队成员能力分析和盘点，制定人员能力提升计划，确保人员能力的持续提升; Establish team training system and SME development system. Be responsible for all relevant personnel have received necessary pre-job training and continuing training, team member ability analysis, and develop a personnel ability improvement plan to ensure the continuous improvement of personnel ability； 9主动开展业务优化并持续改进，包括不限于运用WBS工具优化运营工作流程，提升工作效率； Initiate business optimization and continuous improvement to improve work efficiency, include but not limited to using WBS methodologies to improve team operation work-flow; 10其他管理工作。 Other management work. . 任职要求 Requirements: 1.全日制大学博士及以上，化学工程、生物工程、生物学、药学等生命科学或工程等相关专业。有海外经验背景。 Bachelor or above, majoring in life sciences or engineering such as chemical engineering, bioengineering, biology, pharmacy, etc. Oversea experience is mandatory. 2.具有至少10年以上的大分子药物或偶联药物生产技术经验，并具有丰富的项目管理和团队管理经验。必须具有商业化支持经验 At least more than 7-10 years technology experience for macromolecular drugs or conjugated drugs manufacturing. Have rich project and team management experience. Commercial experience is mandatory. 3.精通抗体上游、下游及偶联工艺技术知识, 以及技术转移和工艺验证的流程和要求; Expertise in mAb upstream and downstream, and bio-conjugation processes technology. Be familiar with technology transfer and process validation; 4.熟悉抗体和偶联GMP药品生产，熟悉质量体系，对偏差调查、CAPA和变更控制等方面的质量体系有深刻的理解。 Be familiar with sterile pharmaceutical production and quality system. Have a solid understanding of quality system in terms of deviation investigation, CAPA and change control. 5.了解FDA/中国/欧盟法规及ICH等的要求; Be familiar with FDA/China/EU and ICH GMP requirements; 6.良好的沟通、团队合作、逻辑思维能力及执行力，具有一定的抗压能力。 Good communication, teamwork, and logical thinking skills and execution ability, with a certain ability to handle pressure. 7.优秀的英文读写和口语沟通能力。 Excellent English reading and writing and oral communication skills, meeting organization and document writing ability.